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2 Hits

Jobs by e-mail

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    Reference number: 861126/1

    GMP Laboratory Expert (Bioassays) (m/f/d)

    Freelance/Contracting project
    Wien
    • Sample preparation
    • Color development
    • Spectrometric analysis to determine substance potency
    • In-process control testing and release testing, following a highly structured routine 
    • Support in validation and qualification activities across laboratory processes and equipment
    • Preparation and maintenance of GMP/GDDP-compliant documentation
    • Planning, preparation, and execution of laboratory investigations
    • Creation, organization, and handling of laboratory documents
    • Use of Labware (LIMS) for data entry and documentation
    Online since: Wed Feb 11 15:42:26 CET 2026
    Reference number: 858921/1

    Auditor für internes Drug Safety & Medical Affairs Audit mit GVP Fokus (m/f/d)

    Freelance/Contracting project
    Vienna and Remote
    • Audit Planning/Preparation: Training on SOP for internal Audit Management incl. Attachments for Agenda, Audit Report, CAPA Plan, Provision of Audit Agenda
    • Audit Conduct: Leading through the audit process, Definition and classification of audit observations/findings
    • Audit Reporting: Provision of Audit Report draft for internal review (30 days after audit date), Provision of CAPA Plan, filled with Audit Observations/findings, Signing of final Audit Report (should be done latest after 45 days after audit date), Assessment and approval of defined CAPAs within CAPA Plan
    • CAPA review until closure: Review, assessment and approval of closed CAPAs
    • CSR Management, PSMF management, Aggregate Reports & Risk Management, Signal management and safety communication, Quality Management of PV processes (documents, training, audits, vendor oversight etc.), Medical Affairs processes that interface with GxP activities (e.g. Medical Enquiries, Managing Medical Information Requests)
    • The following regulations can be used as guidelines: Regulation 726/2004, Directive 2001/83/EC, Commission Implementing regulation 520/2012, Good Vigilance Practices (GVP) Guideline, Applicable national regulations and guidelines, e.g. Medicines Act
    Online since: Wed Jan 28 13:21:41 CET 2026

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